New Protocol and Amendment Review Procedure
All New Protocol Applications, Amendments, and Exempt Activities forms must be sent as email attachments to the Chair of the IACUC (arumore@randolphcollege.edu).
Upon receipt of an incomplete protocol or amendment, the committee Chair will provide the principal investigator with a list of information, sections, or forms needed to complete the submission.
Once a complete New Protocol, Amendment, or Exempt Activity form is received, the committee Chair categorizes the submission as: New Protocol, Protocol Renewal, Annual Review, Protocol Amendment, or Exempt Activity.
- New Protocols, Protocol Renewals, and Annual Reviews must be reviewed by the Full Committee.
- Amendments that include major survival surgery, physical euthanasia methods, death as an experimental endpoint, or procedures that cause more than minimal or momentary pain or distress without the application of anesthetics, analgesics, or tranquilizers must be reviewed by the Full Committee.
- All other submissions may be reviewed by the Full Committee, OR may be reviewed by a designated member OR administratively reviewed by the committee Chair.
Review Outcomes
- Approved – The new protocol application, amendment, renewal, or exemption is approved with no modifications.
- Approved pending minor modification or clarification – The new protocol application, amendment, renewal, or exemption is conditionally approved pending PI clarification or modification as requested by the IACUC. The committee Chair will provide the PI with a written report detailing requested modification or clarification. The committee chair will notify the PI when the conditions have been fulfilled and the protocol is activated.
- Tabled – The new protocol application, amendment, renewal, or exemption requires additional information and/or the IACUC has a concern. The committee Chair will provide the PI with a written report detailing missing application information and/or the committee’s concerns. The PI must revise and resubmit the protocol application with a letter that clearly identifies application changes and how they address issues brought forth in the committee chair’s written report.
- Review declined – The new protocol application, amendment, renewal, or exemption is missing significant information such that a proper review cannot be performed. Alternately, the PI has failed to follow application instructions. The committee Chair will provide the PI with a written report detailing reasons why the protocol application was returned without review. The PI must revise and resubmit the protocol application, as appropriate.
- Disapproved – The committee chair will provide the PI with a written report detailing reasons why the new protocol application, amendment, renewal, exemption was disapproved. The PI has the right of appeal to the IACUC.
Other Information
All approved protocols must be re-submitted for a de novo review every three (3) years. Failure to re-submit by the protocol expiration date will cause automatic termination of the protocol and require a New Protocol application to be completed before the project can continue.
All exempt activities are active for one year following date of approval at which time they are automatically terminated. There is no renewal process for exempt activities. A new Exempt Activities form must be completed after one year.
Members of the committee may call for a full committee review of previously approved protocols at any time. Moreover, committee members are authorized to monitor, evaluate, observe and inspect animal use and care activities for compliance with an approved protocol.